FDA.reportPublic FDA data

Legacy

Primary DI
E53582460100001
Brand
Legacy
Company
Gc Orthodontics America Inc.
Model
82-4601-0000
Catalog number
82-4601-0000
Device description
LEGACY 1. MOLAR LWR RGT SZ 01
Published
2017-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DYOBAND, MATERIAL, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYOBand, Material, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E53582460100001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic bracket, metalA metallic device that is bonded to an orthodontic band, or directly to a tooth, to hold an orthodontic wire and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the position of the tooth. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(708)897-8859GCOAInfo@gcorthodontics.com

Regulatory Flags#

DUNS number
063167128
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10840539702450Experience50-0300-000050-0300-00002026-05-28
10860013564701Curva50-0041-000050-0041-00002026-05-28
10860013564718Curva50-0040-000050-0041-00002026-05-28
10860013564725Curva50-0512-000050-0041-00002026-05-28
10860013564732Curva50-0513-000050-0041-00002026-05-28
10860013564756Curva50-5610-000050-0041-00002026-05-28
10860013564763Curva50-5000-000050-0041-00002026-05-28
10860013564770Curva50-0043-000050-0041-00002026-05-28
D78887122400001GC Ties87-1224-000087-1224-00002021-08-26
D78887122500001GC Ties87-1225-000087-1225-00002021-08-26
D78887122600001GC Ties87-1226-000087-1226-00002021-08-26
D78887122700001GC Ties87-1227-000087-1227-00002021-08-26
D78887122800001GC Ties87-1228-000087-1228-00002021-08-26
D78887122900001GC Ties87-1229-000087-1229-00002021-08-26
D78887123000001GC Ties87-1230-000087-1230-00002021-08-26
D78887123100001GC Ties87-1231-000087-1231-00002021-08-26
D78887123200001GC Ties87-1232-000087-1232-00002021-08-26
D78887123300001GC Ties87-1233-000087-1233-00002021-08-26
D78887123400001GC Ties87-1234-000087-1234-00002021-08-26
D78887123500001GC Ties87-1235-000087-1235-00002021-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974720061198Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-05-21
06974720061204Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-05-21
06974720061211Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-05-21
06974720061228Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-05-21
06974720061235Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-05-21
06974720061242Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-05-21
006522210247323M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-05-07
006522213044453M™ Unitek™3M UNITEK CORPORATIONDYO2026-04-28
006522213044523M™ Unitek™3M UNITEK CORPORATIONDYO2026-04-28
006522213029843M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213029913M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213030043M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213030113M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213030283M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213030353M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213030423M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213030593M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213030663M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213030733M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213030803M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213030973M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213031033M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213031343M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213031413M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213031583M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213031723M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213031963M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213032023M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213032193M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213032263M™ Unitek™3M UNITEK CORPORATIONDYO2026-04-25